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Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)

Not Applicable
Conditions
ocally advanced pancreatic cancer
Registration Number
JPRN-UMIN000012296
Lead Sponsor
Gunma University Heavy Ion Medical Center
Brief Summary

MST=16.5M Overall survival 1y 69%, 2y 23% Local control 1y 93%, 2y 72% In favorable group (CA19-9 <1000, D95>52.8G), Overall survival 1y 84%, 2y 47% Local control 1y 100%, 2y 76% MST 22.2M

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

1) Past history of irradiation to the target region 2) Infection around the target 3) Metalic stent at the bile duct 4) Pleural effusions or ascites 5) Past history of chemotherapy within 4 weeks before start of this treatment 6) Uncontrolled severe complication 7) Active ulcer of stomach or duodenum 8) Active double cancers 9) Interstitial pneumonia 10) In pregnancy or during the lactation preiod 11) Other medical or psychological unsuitable reasons

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall survival rate
Secondary Outcome Measures
NameTimeMethod
Response rate Local control rate at two year Progression free survival rate Acute and late toxicity
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